drugset / Trial / NCT00002324

The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

NCT00002324 ↗

Phase 2 Completed 250 enrolled Boehringer Ingelheim
Double-blindTreatment

Summary

PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT. SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.

Timeline

Start
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Primary completion
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Completion
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Publications

  • Background Pollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113

Drugs

EvaluationDrugModalityDoseRoute
Subject Nevirapine Small molecule — —
Subject Zidovudine Small molecule — —